Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

May 20, 2009 updated by: Hospital Juarez de Mexico

Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema

The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.

Study Overview

Status

Completed

Conditions

Detailed Description

Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. Differences in research can achieve statistical significance, without clinical significance. A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 07760
        • Hospital Juarez de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Target population were type 2 diabetics from Mexico City and its metropolitan area, accessible population were the patients who attended a General Hospital in Mexico City

Description

Inclusion Criteria:

  • type 2 diabetes
  • regardless of diabetes duration and retinopathy severity level
  • one or both eyes with focal clinically significant macular edema
  • treated with selective or focal photocoagulation
  • visual capacity under subjective refraction before and three weeks after treatment
  • adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it

Exclusion Criteria:

  • patients with myopia over -6.00 diopters
  • any retinal disease different from diabetic retinopathy at the moment of photocoagulation
  • eyes with a thickened posterior vitreous
  • eyes with vitreoretinal traction at the macula
  • if they had required scatter photocoagulation before the three weeks evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
diabetic macular edema
type 2 patients who had been treated with selective photocoagulation for clinically significant macular edema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual capacity (under subjective refractive correction was measured in decimal equivalent)
Time Frame: before the treatment and 3 weeks after photocoagulation
before the treatment and 3 weeks after photocoagulation
center point thickness (measured in µm)
Time Frame: before the treatment and 3 weeks after photocoagulation
before the treatment and 3 weeks after photocoagulation
macular volume (measured in mm3)
Time Frame: before the treatment and 3 weeks after photocoagulation
before the treatment and 3 weeks after photocoagulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Juarez de Mexico

Investigators

  • Study Chair: Virgilio Lima Gomez, MD, MsC, Hospital Juarez de Mexico
  • Study Director: Dulce M Razo Blanco Hernandez, MD, Hospital Juarez de Mexico
  • Principal Investigator: Aleyda S Cruz Diaz, MD, Hospital Juarez de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 20, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HJM 1453/08.02.26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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